Schöndorf Thomas, Karagiannis Efstrathios, Posseldt Richard E K, Forst Thomas, Pfützner Andreas
Institute for Clinical Research and Development, Mainz, Germany.
Diabetes Technol Ther. 2009 Jun;11(6):379-83. doi: 10.1089/dia.2008.0108.
In patients with type 2 diabetes, glycemic control to target goals can only be achieved for a while by single-drug treatment. Antidiabetes therapy has to be adapted according to the individual course of the disease. This trial investigates the impact of Competact (Takeda Pharma, Aachen, Germany) (marketed as ActoplusMet in the United States)-a fixed combination of 850 mg of metformin with 15 mg of pioglitazone-for diabetes treatment in patients with insufficient glycemic control by metformin alone.
This observational drug monitoring trial was performed at 1,480 study sites in Germany, and 4,866 complete patient data sets were included into the final analyses. Mean +/- SD age was 60.8 +/- 9.6 years (2,171 women, 2,691 men; disease duration, 6.7 +/- 4.7 years; body mass index [BMI], 31.0 +/- 5.2 kg/m(2)). In total, 43.8% of the patients received lipid-lowering drugs (antihypertensive medication, 74.3%). Main inclusion criteria were type 2 diabetes, metformin monotherapy, and an initial hemoglobin A1c (HbA1c) value between 6.6% and 9.9%. Parameters of glycemic control (HbA1c, fasting blood glucose [FBG]), blood pressure (BP), inflammation (high-sensitivity C-reactive protein [hsCRP]), and lipid metabolism (total cholesterol, high-density lipoprotein [HDL]-cholesterol, non-HDL-cholesterol, and triglycerides) were collected at baseline and after 4 months.
All investigated parameters improved significantly (all P < 0.001) after 4 months of therapy with Competact (baseline vs. end point: systolic BP, 139.7 +/- 15.1 vs. 134.4 +/- 12.0 mm Hg; diastolic BP, 83.1 +/- 8.9 vs. 80.5 +/- 7.5 mm Hg; HbA1c, 7.8 +/- 1.0% vs. 7.0 +/- 0.8%; FBG, 9.0 +/- 2.6 vs. 7.0 +/- 1.7 mM; cholesterol, 5.7 +/- 1.1 mM vs. 5.3 +/- 0.9 mM; HDL-cholesterol, 1.2 +/- 0.4 mM vs. 1.3 +/- 0.4 mM; non-HDL-cholesterol, 4.5 +/- 1.2 mM vs. 4.0 +/- 0.9 mM; triglycerides, 2.5 +/- 1.0 mM vs. 2.1 +/- 0.8 mM; hsCRP, 3.2 +/- 2.6 mg/L vs. 2.7 +/- 2.3 mg/L). It is noteworthy that the BMI was not affected by Competact (31.0 +/- 5.2 kg/m(2) vs. 31.1 +/- 6.1 kg/m(2), P = 0.221).
These observational results, obtained from a non-selected patient population under daily routine conditions, show the beneficial effects of a pioglitazone/metformin combination for diabetes patients with insufficient glycemic control under daily routine conditions.
在2型糖尿病患者中，单药治疗只能在一段时间内实现血糖控制达标。抗糖尿病治疗必须根据疾病的个体进程进行调整。本试验研究了复方制剂（德国亚琛武田制药公司生产，在美国市场名为ActoplusMet）——一种850毫克二甲双胍与15毫克吡格列酮的固定复方制剂——对仅使用二甲双胍血糖控制不佳的糖尿病患者的治疗效果。
这项观察性药物监测试验在德国的1480个研究地点进行，4866份完整的患者数据集纳入最终分析。平均年龄±标准差为60.8±9.6岁（女性2171例，男性2691例；病程6.7±4.7年；体重指数[BMI]，31.0±5.2kg/m²）。共有43.8%的患者接受降脂药物治疗（74.3%接受抗高血压药物治疗）。主要纳入标准为2型糖尿病、二甲双胍单药治疗以及初始糖化血红蛋白（HbA1c）值在6.6%至9.9%之间。在基线和4个月后收集血糖控制参数（HbA1c、空腹血糖[FBG]）、血压（BP）、炎症指标（高敏C反应蛋白[hsCRP]）和脂质代谢指标（总胆固醇、高密度脂蛋白[HDL]胆固醇、非HDL胆固醇和甘油三酯）。
使用复方制剂治疗4个月后，所有研究参数均显著改善（所有P<0.001）（基线与终点对比：收缩压，139.7±15.1 vs. 134.4±12.0mmHg；舒张压，83.1±8.9 vs. 80.5±7.5mmHg；HbA1c，7.8±1.0% vs. 7.0±0.8%；FBG，9.0±2.6 vs. 7.0±1.7mmol/L；胆固醇，5.7±1.1mmol/L vs. 5.3±0.9mmol/L；HDL胆固醇，1.2±0.4mmol/L vs. 1.3±0.4mmol/L；非HDL胆固醇，4.5±1.2mmol/L vs. 4.0±0.9mmol/L；甘油三酯，2.5±1.0mmol/L vs. 2.1±0.8mmol/L；hsCRP，3.2±2.6mg/L vs. 2.7±2.3mg/L）。值得注意的是，复方制剂对BMI无影响（31.0±5.2kg/m² vs. 31.1±6.1kg/m²，P = 0.221）。
这些在日常常规条件下非选择性患者群体中获得的观察结果显示，吡格列酮/二甲双胍复方制剂对日常常规条件下血糖控制不佳的糖尿病患者具有有益作用。
